Pressure indicator for an oscillating positive expiratory pressure device

ABSTRACT

A pressure indicator for a respiratory treatment device, the pressure indicator including an instrument for measuring pressures, a conduit configured to transmit a pressure within the respiratory treatment device to the instrument, and a pressure stabilizer orifice positioned within the conduit.

RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.14/615,248, filed Feb. 5, 2015, pending, which claims the benefit ofU.S. Provisional Application No. 61/937,433, filed Feb. 7, 2014, theentireties of which are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates to a pressure indicator for a respiratorytreatment device, and in particular, a pressure indicator for anoscillating positive expiratory pressure (“OPEP”) device.

BACKGROUND

Each day, humans may produce upwards of 30 milliliters of sputum, whichis a type of bronchial secretion. Normally, an effective cough issufficient to loosen secretions and clear them from the body's airways.However, for individuals suffering from more significant bronchialobstructions, such as collapsed airways, a single cough may beinsufficient to clear the obstructions.

OPEP therapy represents an effective bronchial hygiene technique for theremoval of bronchial secretions in the human body and is an importantaspect in the treatment and continuing care of patients with bronchialobstructions, such as those suffering from chronic obstructive lungdisease. It is believed that OPEP therapy, or the oscillation ofexhalation pressure at the mouth during exhalation, effectivelytransmits an oscillating back pressure to the lungs, thereby splittingopen obstructed airways and loosening the secretions contributing tobronchial obstructions.

OPEP therapy is an attractive form of treatment because it can be easilytaught to most patients, and such patients can assume responsibility forthe administration of OPEP therapy throughout a hospitalization and alsofrom home. To that end, a number of portable OPEP devices have beendeveloped.

Providing users of such devices with a visual indication of thepressures achieved during OPEP therapy may assist the user and his orher clinician in administering OPEP therapy within a comfortable or apreferred range of pressures, thereby improving treatment results anddecreasing the overall length of treatment. A portable pressureindicator for use with such OPEP devices is disclosed herein.

BRIEF SUMMARY

A pressure indicator for a respiratory treatment device includes aninstrument for measuring pressures, a conduit configured to transmit apressure within the respiratory treatment device to the instrument; anda pressure stabilizer orifice positioned within the conduit. Therespiratory treatment device may be an oscillating positive expiratorypressure device. The instrument may be a manometer.

In another aspect, the instrument may have a passageway that is in fluidcommunication with the conduit. A portion of the conduit may extend intothe passageway. The pressure stabilizer orifice may be positioned withinthe passageway. The pressure stabilizer orifice may be configured todampen oscillations in the pressure transmitted from the respiratorytreatment device to the instrument.

In another aspect, the pressure stabilizer orifice may have across-sectional area between 0.196 mm² and 1.767 mm². The pressurestabilizer office may have a cross-sectional area between 0.283 mm² and0.636 mm². A cross-sectional area of the pressure stabilizer orifice maybe less than a cross-sectional area of the conduit along an entirelength of the conduit. A portion of the conduit may extend into theinstrument or may form part of a passageway in the instrument which isin fluid communication with the conduit. The pressure stabilizer orificemay be positioned within the portion of the conduit extending into theinstrument or may form part of the passageway in the instrument which isin fluid communication with the conduit. The pressure stabilizer orificemay be configured to dampen oscillations in the pressure transmittedfrom the respiratory treatment device to the instrument.

In another aspect, the instrument may include an indicator for providingvisual or auditory feedback to a user of the respiratory treatmentdevice during or after treatment.

In another aspect, the pressure indicator may be permanently orremovably connectable to a mouthpiece of the respiratory treatmentdevice. The pressure indicator may be connectable to the respiratorytreatment device in a position where the flow of air from a user of therespiratory treatment device to an inlet of the conduit is substantiallyunobstructed.

In another aspect, the manometer may include a piston-type gauge.Alternatively, the manometer may include a dial-type gauge.

In another aspect, the instrument may be permanently or removablyconnectable to the respiratory treatment device in a position such thatthe indicator is viewable by a user of the respiratory treatment deviceduring treatment.

In yet another aspect, a method of providing visual feedback duringadministration of oscillating positive expiratory pressure therapyincludes receiving a flow of exhaled air at an inlet of a conduitconnected to an oscillating positive expiratory pressure device,dampening oscillations in a pressure of the exhaled air in the conduitby restricting the flow of exhaled air through a pressure stabilizingorifice within the conduit, measuring the pressure at an outlet of theconduit, and providing an indication of the pressure measured at theoutlet of the conduit

In another aspect, a manometer measures the pressure at an outlet of theconduit. The manometer may include a passageway that is in fluidcommunication with the conduit. A portion of the conduit may extend intothe passageway. The pressure stabilizer orifice may be position withinthe passageway.

In another aspect, the pressure stabilizer orifice may have across-sectional area between 0.196 mm² and 1.767 mm². The pressurestabilizer orifice may have a cross-sectional area between 0.283 mm² and0.636 mm². A cross-sectional area of the pressure stabilizer orifice maybe less than a cross-sectional area of the conduit along an entirelength of the conduit. A portion of the conduit may extend into themanometer. The pressure stabilizer orifice may be positioned within theportion of the conduit extending into the manometer.

In another aspect, the indication may include auditory or visualfeedback.

In another aspect, the conduit may be connectable to a mouthpiece of theoscillating positive expiratory pressure device. The conduit may beconnectable to the oscillating positive expiratory pressure device in aposition where the flow of air from a user of the oscillating positiveexpiratory pressure device to the inlet of the conduit is substantiallyunobstructed.

In another aspect, the manometer may include a piston-type gauge.Alternatively, the manometer may include a dial-type gauge.

In another aspect, the conduit is connectable to the oscillatingpositive expiratory pressure device in a position such that themanometer is viewable by a user of the oscillating positive expiratorypressure device during treatment.

In yet another aspect, a pressure indicator for a respiratory treatmentdevice includes an instrument for measuring pressures, the instrumentcomprising a chamber, a chamber inlet configured to receive a flow ofair from the respiratory treatment device, and a chamber vent in fluidcommunication with an atmosphere surrounding the respiratory treatmentdevice. A pressure stabilizer orifice is positioned within at least oneof the chamber inlet or the chamber vent. The pressure stabilizerorifice has a cross-sectional area smaller than the cross-sectional areaof the inlet or the vent within which the pressure stabilizer orifice ispositioned. The instrument may be a manometer.

In another aspect, the pressure indicator includes a membrane positionedin the chamber. The membrane is configured to divide the chamber suchthat the flow of air through the chamber inlet from the respiratorytreatment device is blocked from passing through the chamber vent.

In another aspect, the chamber vent may include a plurality of openings.The pressure stabilizer orifice may include a plurality of orificespositioned within the openings.

In another aspect, the pressure stabilizer orifice may have across-sectional area between 0.196 mm² and 1.767 mm². The pressurestabilizer orifice may have a cross-sectional area between 0.283 mm² and0.636 mm².

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of an OPEP device;

FIG. 2 is a rear perspective view of the OPEP device of FIG. 1;

FIG. 3 is a cross-sectional perspective view taken along line III inFIG. 1 of the OPEP device shown without the internal components of theOPEP device;

FIG. 4 is an exploded view of the OPEP device of FIG. 1, shown with theinternal components of the OPEP device;

FIG. 5 is a cross-sectional perspective view taken along line III inFIG. 1 of the OPEP device shown with the internal components of the OPEPdevice;

FIG. 6 is a different cross-sectional perspective view taken along lineVI in FIG. 1 of the OPEP device shown with the internal components ofthe OPEP device;

FIG. 7 is a different cross-sectional perspective view taken along lineVII in FIG. 1 of the OPEP device shown with the internal components ofthe OPEP device;

FIG. 8 is a front perspective view of a restrictor member operativelyconnected to a vane;

FIG. 9 is a rear perspective view of the restrictor member operativelyconnected to the vane shown in FIG. 8;

FIG. 10 is a front view of the restrictor member operatively connectedto the vane shown in FIG. 8;

FIG. 11 is a top view of the restrictor member operatively connected tothe vane shown in FIG. 8;

FIG. 12 is a front perspective view of a variable nozzle shown withoutthe flow of exhaled air therethrough;

FIG. 13 is a rear perspective view of the variable nozzle of FIG. 12shown without the flow of exhaled air therethrough;

FIG. 14 is a front perspective view of the variable nozzle of FIG. 12shown with a high flow of exhaled air therethrough;

FIGS. 15A-C are top phantom views of the OPEP device of FIG. 1 showingan exemplary illustration of the operation of the OPEP device of FIG. 1;

FIG. 16 is a front perspective view of a different embodiment of avariable nozzle shown without the flow of exhaled air therethrough;

FIG. 17 is a rear perspective view of the variable nozzle of FIG. 16shown without the flow of exhaled air therethrough;

FIG. 18 is a front perspective view of a second embodiment of an OPEPdevice;

FIG. 19 is a rear perspective view of the OPEP device of FIG. 18;

FIG. 20 is an exploded view of the OPEP device of FIG. 18, shown withthe internal components of the OPEP device;

FIG. 21 is a cross-sectional view taken along line I in FIG. 18 of theOPEP device, shown with the internal components of the OPEP device;

FIG. 22 is a cross-sectional view taken along line II in FIG. 18 of theOPEP device, shown with the internal components of the OPEP device;

FIG. 23 is a cross-sectional view taken along line III in FIG. 18 of theOPEP device, shown with the internal components of the OPEP device;

FIG. 24 is a front perspective view of an adjustment mechanism of theOPEP device of FIG. 18;

FIG. 25 is a rear perspective view of the adjustment mechanism of FIG.24;

FIG. 26 is a front perspective view of a restrictor member operativelyconnected to a vane for use in the OPEP device of FIG. 18;

FIG. 27 is a front perspective view of the adjustment mechanism of FIG.24 assembled with the restrictor member and the vane of FIG. 26;

FIG. 28 is a partial cross-sectional view of the assembly of FIG. 27within the OPEP device of FIG. 18;

FIGS. 29A-B are partial cross-sectional views illustrating installationof the assembly of FIG. 27 within the OPEP device of FIG. 18;

FIG. 30 is a front view of the OPEP device of FIG. 18 illustrating anaspect of the adjustability of the OPEP device;

FIG. 31 is a partial cross-sectional view of the assembly of FIG. 27within the OPEP device of FIG. 18;

FIGS. 32A-B are partial cross-sectional views taken along line III inFIG. 18 of the OPEP device, illustrating possible configurations of theOPEP device;

FIGS. 33A-B are top phantom views illustrating the adjustability of theOPEP device of FIG. 18;

FIGS. 34A-B are top phantom views of the OPEP device of FIG. 18,illustrating the adjustability of the OPEP device;

FIG. 35 is a front perspective view of another embodiment of an OPEPdevice;

FIG. 36 is a rear perspective view of the OPEP device of FIG. 35;

FIG. 37 is a perspective view of the bottom of the OPEP device of FIG.35;

FIG. 38 is an exploded view of the OPEP device of FIG. 35;

FIG. 39 is a cross-sectional view taken along line I in FIG. 35, shownwithout the internal components of the OPEP device;

FIG. 40 is a cross-sectional view taken along line I in FIG. 35, shownwith the internal components of the OPEP device;

FIG. 41 is a front-perspective view of an inner casing of the OPEPdevice of FIG. 35;

FIG. 42 is a cross-sectional view of the inner casing taken along line Iof in FIG. 41;

FIG. 43 is a perspective view of a vane of the OPEP device of FIG. 35;

FIG. 44 is a front perspective view of a restrictor member of the OPEPdevice of FIG. 35;

FIG. 45 is a rear perspective view of the restrictor member of the FIG.44;

FIG. 46 is a front view of the restrictor member of FIG. 44;

FIG. 47 is a front perspective view of an adjustment mechanism of theOPEP device of FIG. 35;

FIG. 48 is a rear perspective view of the adjustment mechanism of FIG.47;

FIG. 49 is a front perspective view of the adjustment mechanism of FIGS.47-48 assembled with the restrictor member of FIGS. 44-46 and the vaneof FIG. 43;

FIG. 50 is a front perspective view of a variable nozzle of the OPEPdevice of FIG. 35;

FIG. 51 is a rear perspective view of the variable nozzle of FIG. 50;

FIG. 52 is a front perspective view of the one-way valve of the OPEPdevice of FIG. 35.

FIG. 53 is a perspective view of a first embodiment of a pressureindicator for an OPEP device;

FIG. 54 is a perspective view of the pressure indicator of FIG. 53connected to the OPEP device of FIG. 35;

FIGS. 55A-B are side and cross-sectional views of the pressure indicatorof FIG. 53;

FIGS. 56A-E are top and cross-sectional views of the pressure indicatorof FIG. 53;

FIGS. 56F-G are various side, phantom, and cross-sectional views of analternative embodiment of the pressure indicator of FIG. 53;

FIGS. 56H-56I provide an illustration comparing the oscillations inpressures observed using the pressure indicator of FIG. 53 without apressure stabilizing orifice to the pressure indicator of FIG. 53 with apressure stabilizing orifice;

FIG. 57 is a perspective view of a second embodiment of a pressureindicator for an OPEP device;

FIG. 58 is a perspective view of the pressure indicator of FIG. 57connected to the OPEP device of FIG. 35;

FIGS. 59A-C are side are top and cross-sectional views of the pressureindicator of FIG. 57;

FIGS. 59D-59E provide an illustration comparing the oscillations inpressures observed using the pressure indicator of FIG. 57 without apressure stabilizing orifice to the pressure indicator of FIG. 57 with apressure stabilizing orifice;

FIG. 60 is a perspective view of a third embodiment of a pressureindicator connected to the OPEP device of FIG. 35;

FIG. 61 is a cross-sectional view of the pressure indicator of FIG. 60connected to the OPEP device of FIG. 35;

FIG. 62 is a side view of a fourth embodiment of a pressure indicatorconnected to the OPEP device of FIG. 35;

FIGS. 63A-B are side and cross-sectional view of the pressure indicatorof FIG. 62;

FIGS. 64A-B are illustrations of a manometer configured with a pressurestabilizing orifice;

FIGS. 65A-B are illustrations of another manometer configured with apressure stabilizing orifice;

FIGS. 66-67 are perspective views of the pressure indicators of FIGS. 53and 57 connected to a commercially available OPEP device;

FIGS. 68-69 are perspective views of the pressure indicators of FIGS. 53and 57 connected to another commercially available OPEP device;

FIGS. 70-71 are perspective views of the pressure indicators of FIGS. 53and 57 connected to another commercially available OPEP device;

FIG. 72 is a perspective view of an alternative embodiment of a pressureindicator, shown without a manometer, which includes features thatprevent unintended installations and restrict use to an approvedrespiratory treatment device;

FIG. 73 is a different perspective view of the pressure indicator ofFIG. 72, shown with a manometer, during an unintended installation onthe OPEP device of FIG. 35; and,

FIG. 74 is a side view of the pressure indicator of FIG. 72, shown witha manometer, after installation on an approved respiratory treatmentdevice, in this case the OPEP device of FIG. 35.

DETAILED DESCRIPTION

OPEP therapy is effective within a range of operating conditions. Forexample, an adult human may have an exhalation flow rate ranging from 10to 60 liters per minute, and may maintain a static exhalation pressurein the range of 8 to 18 cm H₂O. Within these parameters, OPEP therapy isbelieved to be most effective when changes in the exhalation pressure(i.e., the amplitude) range from 5 to 20 cm H₂O oscillating at afrequency of 10 to 40 Hz. In contrast, an adolescent may have a muchlower exhalation flow rate, and may maintain a lower static exhalationpressure, thereby altering the operating conditions most effective forthe administration of OPEP therapy. Likewise, the ideal operatingconditions for someone suffering from a respiratory illness, or incontrast, a healthy athlete, may differ from those of an average adult.As described below, the components of the disclosed OPEP devices areselectable and/or adjustable so that ideal operating conditions (e.g.,amplitude and frequency of oscillating pressure) may be identified andmaintained. Each of the various embodiments described herein achievefrequency and amplitude ranges that fall within the desired ranges setforth above. Each of the various embodiments described herein may alsobe configured to achieve frequencies and amplitudes that fall outsidethe ranges set forth above.

First OPEP Embodiment

Referring first to FIGS. 1-4, a front perspective view, a rearperspective view, a cross-sectional front perspective view, and anexploded view of an OPEP device 100 are shown. For purposes ofillustration, the internal components of the OPEP device 100 are omittedin FIG. 3. The OPEP device 100 generally comprises a housing 102, achamber inlet 104, a first chamber outlet 106, a second chamber outlet108 (best seen in FIGS. 2 and 7), and a mouthpiece 109 in fluidcommunication with the chamber inlet 104. While the mouthpiece 109 isshown in FIGS. 1-4 as being integrally formed with the housing 102, itis envisioned that the mouthpiece 109 may be removable and replaceablewith a mouthpiece 109 of a different size or shape, as required tomaintain ideal operating conditions. In general, the housing 102 and themouthpiece 109 may be constructed of any durable material, such as apolymer. One such material is Polypropylene. Alternatively,acrylonitrile butadiene styrene (ABS) may be used.

Alternatively, other or additional interfaces, such as breathing tubesor gas masks (not shown) may be attached in fluid communication with themouthpiece 109 and/or associated with the housing 102. For example, thehousing 102 may include an inhalation port (not shown) having a separateone-way inhalation valve (not shown) in fluid communication with themouthpiece 109 to permit a user of the OPEP device 100 both to inhalethe surrounding air through the one-way valve, and to exhale through thechamber inlet 104 without withdrawing the mouthpiece 109 of the OPEPdevice 100 between periods of inhalation and exhalation. In addition,any number of aerosol delivery devices may be connected to the OPEPdevice 100, for example, through the inhalation port mentioned above,for the simultaneous administration of aerosol and OPEP therapies. Assuch, the inhalation port may include, for example, an elastomericadapter, or other flexible adapter, capable of accommodating thedifferent mouthpieces or outlets of the particular aerosol deliverydevice that a user intends to use with the OPEP device 100. As usedherein, the term aerosol delivery devices should be understood toinclude, for example, without limitation, any nebulizer, soft mistinhaler, pressurized metered dose inhaler, dry powder inhaler,combination of a holding chamber a pressurized metered dose inhaler, orthe like. Suitable commercially available aerosol delivery devicesinclude, without limitation, the AEROECLIPSE nebulizer, RESPIMAT softmist inhaler, LC Sprint nebulizer, AEROCHAMBER PLUS holding chambers,MICRO MIST nebulizer, SIDESTREAM nebulizers, Inspiration Elitenebulizers, FLOVENT pMDI, VENTOLIN pMDI, AZMACORT pMDI, BECLOVENT pMDI,QVAR pMDI and AEROBID PMDI, XOPENEX pMDI, PROAIR pMDI, PROVENT pMDI,SYMBICORT pMDI, TURBOHALER DPI, and DISKHALER DPI. Descriptions ofsuitable aerosol delivery devices may be found in U.S. Pat. Nos.4,566,452; 5,012,803; 5,012,804; 5,312,046; 5,497,944; 5,622,162;5,823,179; 6,293,279; 6,435,177; 6,484,717; 6,848,443; 7,360,537;7,568,480; and, 7,905,228, the entireties of which are hereinincorporated by reference.

In FIGS. 1-4, the housing 102 is generally box-shaped. However, ahousing 102 of any shape may be used. Furthermore, the chamber inlet104, the first chamber outlet 106, and the second chamber outlet 108could be any shape or series of shapes, such as a plurality (i.e., morethan one) of circular passages or linear slots. More importantly, itshould be appreciated that the cross-sectional area of the chamber inlet104, the first chamber outlet 106, and the second chamber outlet 108 areonly a few of the factors influencing the ideal operating conditionsdescribed above.

Preferably, the housing 102 is openable so that the components containedtherein can be periodically accessed, cleaned, replaced, orreconfigured, as required to maintain the ideal operating conditions. Assuch, the housing 102 is shown in FIGS. 1-4 as comprising a frontsection 101, a middle section 103, and a rear section 105. The frontsection 101, the middle section 103, and the rear section 105 may beremovably connected to one another by any suitable means, such as asnap-fit, a compression fit, etc., such that a seal forms between therelative sections sufficient to permit the OPEP device 100 to properlyadminister OPEP therapy.

As shown in FIG. 3, an exhalation flow path 110, identified by a dashedline, is defined between the mouthpiece 109 and at least one of thefirst chamber outlet 106 and the second chamber outlet 108 (best seen inFIG. 7). More specifically, the exhalation flow path 110 begins at themouthpiece 109, passes through the chamber inlet 104, and enters into afirst chamber 114, or an entry chamber. In the first chamber 114, theexhalation flow path makes a 180-degree turn, passes through a chamberpassage 116, and enters into a second chamber 118, or an exit chamber.In the second chamber 118, the exhalation flow path 110 may exit theOPEP device 100 through at least one of the first chamber outlet 106 andthe second chamber outlet 108. In this way, the exhalation flow path 110is “folded” upon itself, i.e., it reverses longitudinal directionsbetween the chamber inlet 104 and one of the first chamber outlet 106 orthe second chamber outlet 108. However, those skilled in the art willappreciate that the exhalation flow path 110 identified by the dashedline is exemplary, and that air exhaled into the OPEP device 100 mayflow in any number of directions or paths as it traverses from themouthpiece 109 or chamber inlet 104 and the first chamber outlet 106 orthe second chamber outlet 108.

FIG. 3 also shows various other features of the OPEP device 100associated with the housing 102. For example, a stop 122 prevents arestrictor member 130 (see FIG. 5), described below, from opening in awrong direction; a seat 124 shaped to accommodate the restrictor member130 is formed about the chamber inlet 104; and, an upper bearing 126 anda lower bearing 128 are formed within the housing 102 and configured toaccommodate a shaft rotatably mounted therebetween. One or more guidewalls 120 are positioned in the second chamber 118 to direct exhaled airalong the exhalation flow path 110.

Turning to FIGS. 5-7, various cross-sectional perspective views of theOPEP device 100 are shown with its internal components. The internalcomponents of the OPEP device 100 comprise a restrictor member 130, avane 132, and an optional variable nozzle 136. As shown, the restrictormember 130 and the vane 132 are operatively connected by means of ashaft 134 rotatably mounted between the upper bearing 126 and the lowerbearing 128, such that the restrictor member 130 and the vane 132 arerotatable in unison about the shaft 134. As described below in furtherdetail, the variable nozzle 136 includes an orifice 138 configured toincrease in size in response to the flow of exhaled air therethrough.

FIGS. 4-6 further illustrate the division of the first chamber 114 andthe second chamber 118 within the housing 102. As previously described,the chamber inlet 104 defines an entrance to the first chamber 114. Therestrictor member 130 is positioned in the first chamber 114 relative toa seat 124 about the chamber inlet 104 such that it is moveable betweena closed position, where a flow of exhaled air along the exhalation flowpath 110 through the chamber inlet 104 is restricted, and an openposition, where the flow of exhaled air through the chamber inlet 104 isless restricted. Likewise, the variable nozzle 136, which is optional,is mounted about or positioned in the chamber passage 116, such that theflow of exhaled air entering the first chamber 114 exits the firstchamber 114 through the orifice 138 of the variable nozzle 136. Exhaledair exiting the first chamber 114 through the orifice 138 of thevariable nozzle 136 enters the second chamber, which is defined by thespace within the housing 102 occupied by the vane 132 and the guidewalls 120. Depending on the position of the vane 132, the exhaled air isthen able to exit the second chamber 118 through at least one of thefirst chamber outlet 106 and the second chamber outlet 108.

FIGS. 8-14 show the internal components of the OPEP device 100 ingreater detail. Turning first to FIGS. 8-9, a front perspective view anda rear perspective view shows the restrictor member 130 operativelyconnected to the vane 132 by the shaft 134. As such, the restrictormember 130 and the vane 132 are rotatable about the shaft 134 such thatrotation of the restrictor member 130 results in a correspondingrotation of the vane 132, and vice-versa. Like the housing 102, therestrictor member 130 and the vane 132 may be made of constructed of anydurable material, such as a polymer. Preferably, they are constructed ofa low shrink, low friction plastic. One such material is acetal.

As shown, the restrictor member 130, the vane 132, and the shaft 134 areformed as a unitary component. The restrictor member 130 is generallydisk-shaped, and the vane 132 is planar. The restrictor member 130includes a generally circular face 140 axially offset from the shaft 134and a beveled or chamfered edge 142 shaped to engage the seat 124 formedabout the chamber inlet 104. In this way, the restrictor member 130 isadapted to move relative to the chamber inlet 104 about an axis ofrotation defined by the shaft 134 such that the restrictor member 130may engage the seat 124 in a closed position to substantially seal andrestrict the flow of exhaled air through the chamber inlet 104. However,it is envisioned that the restrictor member 130 and the vane 132 may beformed as separate components connectable by any suitable means suchthat they remain independently replaceable with a restrictor member 130or a vane 132 of a different shape, size, or weight, as selected tomaintain ideal operating conditions. For example, the restrictor member130 and/or the vane 132 may include one or more contoured surfaces.Alternatively, the restrictor member 130 may be configured as abutterfly valve.

Turning to FIG. 10, a front view of the restrictor member 130 and thevane 132 is shown. As previously described, the restrictor member 130comprises a generally circular face 140 axially offset from the shaft134. The restrictor member 130 further comprises a second offsetdesigned to facilitate movement of the restrictor member 130 between aclosed position and an open position. More specifically, a center 144 ofthe face 140 of the restrictor member 130 is offset from the planedefined by the radial offset and the shaft 134, or the axis of rotation.In other words, a greater surface area of the face 140 of the restrictormember 130 is positioned on one side of the shaft 134 than on the otherside of the shaft 134. Pressure at the chamber inlet 104 derived fromexhaled air produces a force acting on the face 140 of the restrictormember 130. Because the center 144 of the face 140 of the restrictormember 130 is offset as described above, a resulting force differentialcreates a torque about the shaft 134. As further explained below, thistorque facilitates movement of the restrictor member 130 between aclosed position and an open position.

Turning to FIG. 11, a top view of the restrictor member 130 and the vane132 is shown. As illustrated, the vane 132 is connected to the shaft 134at a 75° angle relative to the face 140 of restrictor member 130.Preferably, the angle will remain between 60° and 80°, although it isenvisioned that the angle of the vane 132 may be selectively adjusted tomaintain the ideal operating conditions, as previously discussed. It isalso preferable that the vane 132 and the restrictor member 130 areconfigured such that when the OPEP device 100 is fully assembled, theangle between a centerline of the variable nozzle 136 and the vane 132is between 10° and 25° when the restrictor member 130 is in a closedposition. Moreover, regardless of the configuration, it is preferablethat the combination of the restrictor member 130 and the vane 132 havea center of gravity aligned with the shaft 134, or the axis of rotation.In full view of the present disclosure, it should be apparent to thoseskilled in the art that the angle of the vane 132 may be limited by thesize or shape of the housing 102, and will generally be less than halfthe total rotation of the vane 132 and the restrictor member 130.

Turning to FIGS. 12 and 13, a front perspective view and a rearperspective view of the variable nozzle 136 is shown without the flow ofexhaled air therethrough. In general, the variable nozzle 136 includestop and bottom walls 146, side walls 148, and V-shaped slits 150 formedtherebetween. As shown, the variable nozzle is generally shaped like aduck-bill type valve. However, it should be appreciated that nozzles orvalves of other shapes and sizes may also be used. The variable nozzle136 may also include a lip 152 configured to mount the variable nozzle136 within the housing 102 between the first chamber 114 and the secondchamber 118. The variable nozzle 136 may be constructed or molded of anymaterial having a suitable flexibility, such as silicone, and preferablywith a wall thickness of between 0.50 and 2.00 millimeters, and anorifice width between 0.25 to 1.00 millimeters or smaller depending onmanufacturing capabilities.

As previously described, the variable nozzle 136 is optional in theoperation of the OPEP device 100. It should also be appreciated that theOPEP device 100 could alternatively omit both the chamber passage 116and the variable nozzle 136, and thus comprise a single-chamberembodiment. Although functional without the variable nozzle 136, theperformance of the OPEP device 100 over a wider range of exhalation flowrates is improved when the OPEP device 100 is operated with the variablenozzle 136. The chamber passage 116, when used without the variablenozzle 136, or the orifice 138 of the variable nozzle 136, when thevariable nozzle 136 is included, serves to create a jet of exhaled airhaving an increased velocity. As explained in more detail below, theincreased velocity of the exhaled air entering the second chamber 118results in a proportional increase in the force applied by the exhaledair to the vane 132, and in turn, an increased torque about the shaft134, all of which affect the ideal operating conditions.

Without the variable nozzle 136, the orifice between the first chamber114 and the second chamber 118 is fixed according to the size, shape,and cross-sectional area of the chamber passage 116, which may beselectively adjusted by any suitable means, such as replacement of themiddle section 103 or the rear section 105 of the housing. On the otherhand, when the variable nozzle 136 is included in the OPEP device 100,the orifice between the first chamber 114 and the second chamber 118 isdefined by the size, shape, and cross-sectional area of the orifice 138of the variable nozzle 136, which may vary according to the flow rate ofexhaled air and/or the pressure in the first chamber 114.

Turning to FIG. 14, a front perspective view of the variable nozzle 136is shown with a flow of exhaled air therethrough. One aspect of thevariable nozzle 136 shown in FIG. 14 is that, as the orifice 138 opensin response to the flow of exhaled air therethrough, the cross-sectionalshape of the orifice 138 remains generally rectangular, which during theadministration of OPEP therapy results in a lower drop in pressurethrough the variable nozzle 136 from the first chamber 114 (See FIGS. 3and 5) to the second chamber 118. The generally consistent rectangularshape of the orifice 138 of the variable nozzle 136 during increasedflow rates is achieved by the V-shaped slits 150 formed between the topand bottom walls 146 and the side walls 148, which serve to permit theside walls 148 to flex without restriction. Preferably, the V-shapedslits 150 are as thin as possible to minimize the leakage of exhaled airtherethrough. For example, the V-shaped slits 150 may be approximately0.25 millimeters wide, but depending on manufacturing capabilities,could range between 0.10 and 0.50 millimeters. Exhaled air that doesleak through the V-shaped slits 150 is ultimately directed along theexhalation flow path by the guide walls 120 in the second chamber 118protruding from the housing 102.

It should be appreciated that numerous factors contribute to the impactthe variable nozzle 136 has on the performance of the OPEP device 100,including the geometry and material of the variable nozzle 136. By wayof example only, in order to attain a target oscillating pressurefrequency of between 10 to 13 Hz at an exhalation flow rate of 15 litersper minute, in one embodiment, a 1.0 by 20.0 millimeter passage ororifice may be utilized. However, as the exhalation flow rate increases,the frequency of the oscillating pressure in that embodiment alsoincreases, though at a rate too quickly in comparison to the targetfrequency. In order to attain a target oscillating pressure frequency ofbetween 18 to 20 Hz at an exhalation flow rate of 45 liters per minute,the same embodiment may utilize a 3.0 by 20.0 millimeter passage ororifice. Such a relationship demonstrates the desirability of a passageor orifice that expands in cross-sectional area as the exhalation flowrate increases in order to limit the drop in pressure across thevariable nozzle 136.

Turning to FIGS. 15A-C, top phantom views of the OPEP device 100 show anexemplary illustration of the operation of the OPEP device 100.Specifically, FIG. 15A shows the restrictor member 130 in an initial, orclosed position, where the flow of exhaled air through the chamber inlet104 is restricted, and the vane 132 is in a first position, directingthe flow of exhaled air toward the first chamber outlet 106. FIG. 15Bshows this restrictor member 130 in a partially open position, where theflow of exhaled air through the chamber inlet 104 is less restricted,and the vane 132 is directly aligned with the jet of exhaled air exitingthe variable nozzle 136. FIG. 15C shows the restrictor member 130 in anopen position, where the flow of exhaled air through the chamber inlet104 is even less restricted, and the vane 132 is in a second position,directing the flow of exhaled air toward the second chamber outlet 108.It should be appreciated that the cycle described below is merelyexemplary of the operation of the OPEP device 100, and that numerousfactors may affect operation of the OPEP device 100 in a manner thatresults in a deviation from the described cycle. However, during theoperation of the OPEP device 100, the restrictor member 130 and the vane132 will generally reciprocate between the positions shown in FIGS. 15Aand 15C.

During the administration of OPEP therapy, the restrictor member 130 andthe vane 132 may be initially positioned as shown in FIG. 15A. In thisposition, the restrictor member 130 is in a closed position, where theflow of exhaled air along the exhalation path through the chamber inlet104 is substantially restricted. As such, an exhalation pressure at thechamber inlet 104 begins to increase when a user exhales into themouthpiece 108. As the exhalation pressure at the chamber inlet 104increases, a corresponding force acting on the face 140 of therestrictor member 130 increases. As previously explained, because thecenter 144 of the face 140 is offset from the plane defined by theradial offset and the shaft 134, a resulting net force creates anegative or opening torque about the shaft. In turn, the opening torquebiases the restrictor member 130 to rotate open, letting exhaled airenter the first chamber 114, and biases the vane 132 away from its firstposition. As the restrictor member 130 opens and exhaled air is let intothe first chamber 114, the pressure at the chamber inlet 104 begins todecrease, the force acting on the face 140 of the restrictor memberbegins to decrease, and the torque biasing the restrictor member 130open begins to decrease.

As exhaled air continues to enter the first chamber 114 through thechamber inlet 104, it is directed along the exhalation flow path 110 bythe housing 102 until it reaches the chamber passage 116 disposedbetween the first chamber 114 and the second chamber 118. If the OPEPdevice 100 is being operated without the variable nozzle 136, theexhaled air accelerates through the chamber passage 116 due to thedecrease in cross-sectional area to form a jet of exhaled air. Likewise,if the OPEP device 100 is being operated with the variable nozzle 136,the exhaled air accelerates through the orifice 138 of the variablenozzle 136, where the pressure through the orifice 138 causes the sidewalls 148 of the variable nozzle 136 to flex outward, thereby increasingthe size of the orifice 138, as well as the resulting flow of exhaledair therethrough. To the extent some exhaled air leaks out of theV-shaped slits 150 of the variable nozzle 136, it is directed backtoward the jet of exhaled air and along the exhalation flow path by theguide walls 120 protruding into the housing 102.

Then, as the exhaled air exits the first chamber 114 through thevariable nozzle 136 and/or chamber passage 116 and enters the secondchamber 118, it is directed by the vane 132 toward the front section 101of the housing 102, where it is forced to reverse directions beforeexiting the OPEP device 100 through the open first chamber exit 106. Asa result of the change in direction of the exhaled air toward the frontsection 101 of the housing 102, a pressure accumulates in the secondchamber 118 near the front section 101 of the housing 102, therebyresulting in a force on the adjacent vane 132, and creating anadditional negative or opening torque about the shaft 134. The combinedopening torques created about the shaft 134 from the forces acting onthe face 140 of the restrictor member 130 and the vane 132 cause therestrictor member 130 and the vane 132 to rotate about the shaft 134from the position shown in FIG. 15A toward the position shown in FIG.15B.

When the restrictor member 130 and the vane 132 rotate to the positionshown in FIG. 15B, the vane 132 crosses the jet of exhaled air exitingthe variable nozzle 136 or the chamber passage 116. Initially, the jetof exhaled air exiting the variable nozzle 136 or chamber passage 116provides a force on the vane 132 that, along with the momentum of thevane 132, the shaft 134, and the restrictor member 130, propels the vane132 and the restrictor member 130 to the position shown in FIG. 15C.However, around the position shown in FIG. 15B, the force acting on thevane 132 from the exhaled air exiting the variable nozzle 136 alsoswitches from a negative or opening torque to a positive or closingtorque. More specifically, as the exhaled air exits the first chamber114 through the variable nozzle 136 and enters the second chamber 118,it is directed by the vane 132 toward the front section 101 of thehousing 102, where it is forced to reverse directions before exiting theOPEP device 100 through the open second chamber exit 108. As a result ofthe change in direction of the exhaled air toward the front section 101of the housing 102, a pressure accumulates in the second chamber 118near the front section 101 of the housing 102, thereby resulting in aforce on the adjacent vane 132, and creating a positive or closingtorque about the shaft 134. As the vane 132 and the restrictor member130 continue to move closer to the position shown in FIG. 15C, thepressure accumulating in the section chamber 118 near the front section101 of the housing 102, and in turn, the positive or closing torqueabout the shaft 134, continues to increase, as the flow of exhaled airalong the exhalation flow path 110 and through the chamber inlet 104 iseven less restricted. Meanwhile, although the torque about the shaft 134from the force acting on the restrictor member 130 also switches from anegative or opening torque to a positive or closing torque around theposition shown in FIG. 15B, its magnitude is essentially negligible asthe restrictor member 130 and the vane 132 rotate from the positionshown in FIG. 15B to the position shown in FIG. 15C.

After reaching the position shown in FIG. 15C, and due to the increasedpositive or closing torque about the shaft 134, the vane 132 and therestrictor member 130 reverse directions and begin to rotate back towardthe position shown in FIG. 15B. As the vane 132 and the restrictormember 130 approach the position shown in FIG. 15B, and the flow ofexhaled through the chamber inlet 104 is increasingly restricted, thepositive or closing torque about the shaft 134 begins to decrease. Whenthe restrictor member 130 and the vane 132 reach the position 130 shownin FIG. 15B, the vane 132 crosses the jet of exhaled air exiting thevariable nozzle 136 or the chamber passage 116, thereby creating a forceon the vane 132 that, along with the momentum of the vane 132, the shaft134, and the restrictor member 130, propels the vane 132 and therestrictor member 130 back to the position shown in FIG. 15A. After therestrictor member 130 and the vane 132 return to the position shown inFIG. 15A, the flow of exhaled air through the chamber inlet 104 isrestricted, and the cycle described above repeats itself.

It should be appreciated that, during a single period of exhalation, thecycle described above will repeat numerous times. Thus, by repeatedlymoving the restrictor member 130 between a closed position, where theflow of exhaled air through the chamber inlet 104 is restricted, and anopen position, where the flow of exhaled air through the chamber inlet104 is less restricted, an oscillating back pressure is transmitted tothe user of the OPEP device 100 and OPEP therapy is administered.

Turning now to FIGS. 16-17, an alternative embodiment of a variablenozzle 236 is shown. The variable nozzle 236 may be used in the OPEPdevice 100 as an alternative to the variable nozzle 136 described above.As shown in FIGS. 16-17, the variable nozzle 236 includes an orifice238, top and bottom walls 246, side walls 248, and a lip 252 configuredto mount the variable nozzle 236 within the housing of the OPEP device100 between the first chamber 114 and the second chamber 118 in the samemanner as the variable nozzle 136. Similar to the variable nozzle 136shown in FIGS. 12-13, the variable nozzle 236 may be constructed ormolded of any material having a suitable flexibility, such as silicone.

During the administration of OPEP therapy, as the orifice 238 of thevariable nozzle 236 opens in response to the flow of exhaled airtherethrough, the cross-sectional shape of the orifice 238 remainsgenerally rectangular, which results in a lower drop in pressure throughthe variable nozzle 236 from the first chamber 114 to the second chamber118. The generally consistent rectangular shape of the orifice 238 ofthe variable nozzle 236 during increased flow rates is achieved by thin,creased walls formed in the top and bottom walls 246, which allow theside walls 248 to flex easier and with less resistance. A furtheradvantage of this embodiment is that there is no leakage out of the topand bottom walls 246 while exhaled air flows through the orifice 238 ofthe variable nozzle 236, such as for example, through the V-shaped slits150 of the variable nozzle 136 shown in FIGS. 12-13.

Those skilled in the art will also appreciate that, in someapplications, only positive expiratory pressure (without oscillation)may be desired, in which case the OPEP device 100 may be operatedwithout the restrictor member 130, but with a fixed orifice or manuallyadjustable orifice instead. The positive expiratory pressure embodimentmay also comprise the variable nozzle 136, or the variable nozzle 236,in order to maintain a relatively consistent back pressure within adesired range.

Second OPEP Embodiment

Turning now to FIGS. 18-19, a front perspective view and a rearperspective view of a second embodiment of an OPEP device 200 is shown.The configuration and operation of the OPEP device 200 is similar tothat of the OPEP device 100. However, as best shown in FIGS. 20-24, theOPEP device 200 further includes an adjustment mechanism 253 adapted tochange the relative position of the chamber inlet 204 with respect tothe housing 202 and the restrictor member 230, which in turn changes therange of rotation of the vane 232 operatively connected thereto. Asexplained below, a user is therefore able to conveniently adjust boththe frequency and the amplitude of the OPEP therapy administered by theOPEP device 200 without opening the housing 202 and disassembling thecomponents of the OPEP device 200.

The OPEP device 200 generally comprises a housing 202, a chamber inlet204, a first chamber outlet 206 (best seen in FIGS. 23 and 32), a secondchamber outlet 208 (best seen in FIGS. 23 and 32), and a mouthpiece 209in fluid communication with the chamber inlet 204. As with the OPEPdevice 100, a front section 201, a middle section 203, and a rearsection 205 of the housing 202 are separable so that the componentscontained therein can be periodically accessed, cleaned, replaced, orreconfigured, as required to maintain the ideal operating conditions.The OPEP device also includes an adjustment dial 254, as describedbelow.

As discussed above in relation to the OPEP device 100, the OPEP device200 may be adapted for use with other or additional interfaces, such asan aerosol delivery device. In this regard, the OPEP device 200 isequipped with an inhalation port 211 (best seen in FIGS. 19, 21, and 23)in fluid communication with the mouthpiece 209 and the chamber inlet204. As noted above, the inhalation port may include a separate one-wayvalve (not shown) to permit a user of the OPEP device 200 both to inhalethe surrounding air through the one-way valve and to exhale through thechamber inlet 204 without withdrawing the mouthpiece 209 of the OPEPdevice 200 between periods of inhalation and exhalation. In addition,the aforementioned aerosol delivery devices may be connected to theinhalation port 211 for the simultaneous administration of aerosol andOPEP therapies.

An exploded view of the OPEP device 200 is shown in FIG. 20. In additionto the components of the housing described above, the OPEP device 200includes a restrictor member 230 operatively connected to a vane 232 bya pin 231, an adjustment mechanism 253, and a variable nozzle 236. Asshown in the cross-sectional view of FIG. 21, when the OPEP device 200is in use, the variable nozzle 236 is positioned between the middlesection 203 and the rear section 205 of the housing 202, and theadjustment mechanism 253, the restrictor member 230, and the vane 232form an assembly.

Turning to FIGS. 21-23, various cross-sectional perspective views of theOPEP device 200 are shown. As with the OPEP device 100, an exhalationflow path 210, identified by a dashed line, is defined between themouthpiece 209 and at least one of the first chamber outlet 206 and thesecond chamber outlet 208 (best seen in FIGS. 23 and 32). As a result ofa one-way valve (not-shown) and/or an aerosol delivery device (notshown) attached to the inhalation port 211, the exhalation flow path 210begins at the mouthpiece 209 and is directed toward the chamber inlet204, which in operation may or may not be blocked by the restrictormember 230. After passing through the chamber inlet 204, the exhalationflow path 210 enters a first chamber 214 and makes a 180° turn towardthe variable nozzle 236. After passing through the orifice 238 of thevariable nozzle 236, the exhalation flow path 210 enters a secondchamber 218. In the second chamber 218, the exhalation flow path 210 mayexit the OPEP device 200 through at least one of the first chamberoutlet 206 or the second chamber outlet 208. Those skilled in the artwill appreciate that the exhalation flow path 210 identified by thedashed line is exemplary, and that air exhaled into the OPEP device 200may flow in any number of directions or paths as it traverses from themouthpiece 209 or chamber inlet 204 to the first chamber outlet 206 orthe second chamber outlet 208.

Referring to FIGS. 24-25, front and rear perspective views of theadjustment mechanism 253 of the OPEP device 200 are shown. In general,the adjustment mechanism 253 includes an adjustment dial 254, a shaft255, and a frame 256. A protrusion 258 is positioned on a rear face 260of the adjustment dial, and is adapted to limit the selective rotationof the adjustment mechanism 253 by a user, as further described below.The shaft 255 includes keyed portions 262 adapted to fit within upperand lower bearings 226, 228 formed in the housing 200 (see FIGS. 21 and28-29). The shaft further includes an axial bore 264 configured toreceive the pin 231 operatively connecting the restrictor member 230 andthe vane 232. As shown, the frame 256 is spherical, and as explainedbelow, is configured to rotate relative to the housing 202, whileforming a seal between the housing 202 and the frame 256 sufficient topermit the administration of OPEP therapy. The frame 256 includes acircular opening defined by a seat 224 adapted to accommodate therestrictor member 230. In use, the circular opening functions as thechamber inlet 204. The frame 256 also includes a stop 222 for preventingthe restrictor member 230 from opening in a wrong direction.

Turning to FIG. 26, a front perspective view of the restrictor member230 and the vane 232 is shown. The design, materials, and configurationof the restrictor member 230 and the vane 232 may be the same asdescribed above in regards to the OPEP device 100. However, therestrictor member 230 and the vane 232 in the OPEP device 200 areoperatively connected by a pin 231 adapted for insertion through theaxial bore 264 in the shaft 255 of the adjustment mechanism 253. The pin231 may be constructed, for example, by stainless steel. In this way,rotation of the restrictor member 230 results in a correspondingrotation of the vane 232, and vice versa.

Turning to FIG. 27, a front perspective view of the adjustment mechanism253 assembled with the restrictor member 230 and the vane 232 is shown.In this configuration, it can be seen that the restrictor member 230 ispositioned such that it is rotatable relative to the frame 256 and theseat 224 between a closed position (as shown), where a flow of exhaledair along the exhalation flow path 210 through the chamber inlet 204 isrestricted, and an open position (not shown), where the flow of exhaledair through the chamber inlet 204 is less restricted. As previouslymentioned the vane 232 is operatively connected to the restrictor member230 by the pin 231 extending through shaft 255, and is adapted to movein unison with the restrictor member 230. It can further be seen thatthe restrictor member 230 and the vane 232 are supported by theadjustment mechanism 253, which itself is rotatable within the housing202 of the OPEP device 200, as explained below.

FIGS. 28 and 29A-B are partial cross-sectional views illustrating theadjustment mechanism 253 mounted within the housing 202 of the OPEPdevice 200. As shown in FIG. 28, the adjustment mechanism 253, as wellas the restrictor member 230 and the vane 232, are rotatably mountedwithin the housing 200 about an upper and lower bearing 226, 228, suchthat a user is able to rotate the adjustment mechanism 253 using theadjustment dial 254. FIGS. 29A-29B further illustrates the process ofmounting and locking the adjustment mechanism 253 within the lowerbearing 228 of the housing 202. More specifically, the keyed portion 262of the shaft 255 is aligned with and inserted through a rotational lock266 formed in the housing 202, as shown in FIG. 29A. Once the keyedportion 262 of the shaft 255 is inserted through the rotational lock266, the shaft 255 is rotated 90° to a locked position, but remains freeto rotate. The adjustment mechanism 253 is mounted and locked within theupper bearing 226 in the same manner.

Once the housing 200 and the internal components of the OPEP device 200are assembled, the rotation of the shaft 255 is restricted to keep itwithin a locked position in the rotational lock 266. As shown in a frontview of the OPEP device 200 in FIG. 30, two stops 268, 288 arepositioned on the housing 202 such that they engage the protrusion 258formed on the rear face 260 of the adjustment dial 254 when a userrotates the adjustment dial 254 to a predetermined position. Forpurposes of illustration, the OPEP device 200 is shown in FIG. 30without the adjustment dial 254 or the adjustment mechanism 253, whichwould extend from the housing 202 through an opening 269. In this way,rotation of the adjustment dial 254, the adjustment mechanism 253, andthe keyed portion 262 of the shaft 255 can be appropriately restricted.

Turning to FIG. 31, a partial cross-sectional view of the adjustmentmechanism 253 mounted within the housing 200 is shown. As previouslymentioned, the frame 256 of the adjustment mechanism 253 is spherical,and is configured to rotate relative to the housing 202, while forming aseal between the housing 202 and the frame 256 sufficient to permit theadministration of OPEP therapy. As shown in FIG. 31, a flexible cylinder271 extending from the housing 202 completely surrounds a portion of theframe 256 to form a sealing edge 270. Like the housing 202 and therestrictor member 230, the flexible cylinder 271 and the frame 256 maybe constructed of a low shrink, low friction plastic. One such materialis acetal. In this way, the sealing edge 270 contacts the frame 256 fora full 360° and forms a seal throughout the permissible rotation of theadjustment member 253.

The selective adjustment of the OPEP device 200 will now be describedwith reference to FIGS. 32A-B, 33A-B, and 34A-B. FIGS. 32A-B are partialcross-sectional views of the OPEP device 200; FIGS. 33A-B areillustrations of the adjustability of the OPEP device 200; and, FIGS.34A-B are top phantom views of the OPEP device 200. As previouslymentioned with regards to the OPEP device 100, it is preferable that thevane 232 and the restrictor member 230 are configured such that when theOPEP device 200 is fully assembled, the angle between a centerline ofthe variable nozzle 236 and the vane 232 is between 10° and 25° when therestrictor member 230 is in a closed position. However, it should beappreciated that the adjustability of the OPEP device 200 is not limitedto the parameters described herein, and that any number ofconfigurations may be selected for purposes of administering OPEPtherapy within the ideal operating conditions.

FIG. 32A shows the vane 232 at an angle of 10° from the centerline ofthe variable nozzle 236, whereas FIG. 32B shows the vane 232 at an angleof 25° from the centerline of the variable nozzle 236. FIG. 33Aillustrates the necessary position of the frame 256 (shown in phantom)relative to the variable nozzle 236 such that the angle between acenterline of the variable nozzle 236 and the vane 232 is 10° when therestrictor member 230 is in the closed position. FIG. 33B, on the otherhand, illustrates the necessary position of the frame 256 (shown inphantom) relative to the variable nozzle 236 such that the angle betweena centerline of the variable nozzle 236 and the vane 232 is 25° when therestrictor member 230 is in the closed position.

Referring to FIGS. 34A-B, side phantom views of the OPEP device 200 areshown. The configuration shown in FIG. 34A corresponds to theillustrations shown in FIGS. 32A and 33A, wherein the angle between acenterline of the variable nozzle 236 and the vane 232 is 10° when therestrictor member 230 is in the closed position. FIG. 34B, on the otherhand, corresponds to the illustrations shown in FIGS. 32B and 33B,wherein the angle between a centerline of the variable nozzle 236 andthe vane 232 is 25° when the restrictor member 230 is in the closedposition. In other words, the frame 256 of the adjustment member 253 hasbeen rotated counter-clockwise 15°, from the position shown in FIG. 34A,to the position shown in FIG. 34B, thereby also increasing thepermissible rotation of the vane 232.

In this way, a user is able to rotate the adjustment dial 254 toselectively adjust the orientation of the chamber inlet 204 relative tothe restrictor member 230 and the housing 202. For example, a user mayincrease the frequency and amplitude of the OPEP therapy administered bythe OPEP device 200 by rotating the adjustment dial 254, and thereforethe frame 256, toward the position shown in FIG. 34A. Alternatively, auser may decrease the frequency and amplitude of the OPEP therapyadministered by the OPEP device 200 by rotating the adjustment dial 254,and therefore the frame 256, toward the position shown in FIG. 34B.Furthermore, as shown for example in FIGS. 18 and 30, indicia may beprovided to aid the user in the setting of the appropriate configurationof the OPEP device 200.

Operating conditions similar to those described below with reference tothe OPEP device 800 may also be achievable for an OPEP device accordingto the OPEP device 200.

Third OPEP Embodiment

Turning to FIGS. 35-37, another embodiment of an OPEP device 300 isshown. The OPEP device 300 is similar to that of the OPEP device 200 inthat is selectively adjustable. As best seen in FIGS. 35, 37, 40, and49, the OPEP device 300, like the OPEP device 300, includes anadjustment mechanism 353 adapted to change the relative position of achamber inlet 304 with respect to a housing 302 and a restrictor member330, which in turn changes the range of rotation of a vane 332operatively connected thereto. As previously explained with regards tothe OPEP device 200, a user is therefore able to conveniently adjustboth the frequency and the amplitude of the OPEP therapy administered bythe OPEP device 300 without opening the housing 302 and disassemblingthe components of the OPEP device 300. The administration of OPEPtherapy using the OPEP device 300 is otherwise the same as describedabove with regards to the OPEP device 100.

The OPEP device 300 comprises a housing 302 having a front section 301,a rear section 305, and an inner casing 303. As with the previouslydescribed OPEP devices, the front section 301, the rear section 305, andthe inner casing 303 are separable so that the components containedtherein can be periodically accessed, cleaned, replaced, orreconfigured, as required to maintain the ideal operating conditions.For example, as shown in FIGS. 35-37, the front section 301 and the rearsection 305 of the housing 302 are removably connected via a snap fitengagement.

The components of the OPEP device 300 are further illustrated in theexploded view of FIG. 38. In general, in addition to the front section301, the rear section 305, and the inner casing 303, the OPEP device 300further comprises a mouthpiece 309, an inhalation port 311, a one-wayvalve 384 disposed therebetween, an adjustment mechanism 353, arestrictor member 330, a vane 332, and a variable nozzle 336.

As seen in FIGS. 39-40, the inner casing 303 is configured to fit withinthe housing 302 between the front section 301 and the rear section 305,and partially defines a first chamber 314 and a second chamber 318. Theinner casing 303 is shown in further detail in the perspective and crosssectional views shown in FIGS. 41-42. A first chamber outlet 306 and asecond chamber outlet 308 are formed within the inner casing 303. Oneend 385 of the inner casing 303 is adapted to receive the variablenozzle 336 and maintain the variable nozzle 336 between the rear section305 and the inner casing 303. An upper bearing 326 and a lower bearing328 for supporting the adjustment mechanism 353 is formed, at least inpart, within the inner casing 303. Like the flexible cylinder 271 andsealing edge 270 described above with regards to the OPEP device 200,the inner casing 303 also includes a flexible cylinder 371 with asealing edge 370 for engagement about a frame 356 of the adjustmentmechanism 353.

The vane 332 is shown in further detail in the perspective view shown inFIG. 43. A shaft 334 extends from the vane 332 and is keyed to engage acorresponding keyed portion within a bore 365 of the restrictor member330. In this way, the shaft 334 operatively connects the vane 332 withthe restrictor member 330 such that the vane 332 and the restrictormember 330 rotate in unison.

The restrictor member 330 is shown in further detail in the perspectiveviews shown in FIGS. 44-45. The restrictor member 330 includes a keyedbore 365 for receiving the shaft 334 extending from the vane 332, andfurther includes a stop 322 that limits permissible rotation of therestrictor member 330 relative to a seat 324 of the adjustment member353. As shown in the front view of FIG. 46, like the restrictor member330, the restrictor member 330 further comprises an offset designed tofacilitate movement of the restrictor member 330 between a closedposition and an open position. More specifically, a greater surface areaof the face 340 of the restrictor member 330 is positioned on one sideof the bore 365 for receiving the shaft 334 than on the other side ofthe bore 365. As described above with regards to the restrictor member130, this offset produces an opening torque about the shaft 334 duringperiods of exhalation.

The adjustment mechanism 353 is shown in further detail in the front andrear perspective views of FIGS. 47 and 48. In general, the adjustmentmechanism includes a frame 356 adapted to engage the sealing edge 370 ofthe flexible cylinder 371 formed on the inner casing 303. A circularopening in the frame 356 forms a seat 324 shaped to accommodate therestrictor member 330. In this embodiment, the seat 324 also defines thechamber inlet 304. The adjustment mechanism 353 further includes an arm354 configured to extend from the frame 356 to a position beyond thehousing 302 in order to permit a user to selectively adjust theorientation of the adjustment mechanism 353, and therefore the chamberinlet 304, when the OPEP device 300 is fully assembled. The adjustmentmechanism 353 also includes an upper bearing 385 and a lower bearing 386for receiving the shaft 334.

An assembly of the vane 332, the adjustment mechanism 353, and therestrictor member 330 is shown in the perspective view of FIG. 49. Aspreviously explained, the vane 332 and the restrictor member 330 areoperatively connected by the shaft 334 such that rotation of the vane332 results in rotation of the restrictor member 330, and vice versa. Incontrast, the adjustment mechanism 353, and therefore the seat 324defining the chamber inlet 304, is configured to rotate relative to thevane 332 and the restrictor member 330 about the shaft 334. In this way,a user is able to rotate the arm 354 to selectively adjust theorientation of the chamber inlet 304 relative to the restrictor member330 and the housing 302. For example, a user may increase the frequencyand amplitude of the OPEP therapy administered by the OPEP device 800 byrotating the arm 354, and therefore the frame 356, in a clockwisedirection. Alternatively, a user may decrease the frequency andamplitude of the OPEP therapy administered by the OPEP device 300 byrotating the adjustment arm 354, and therefore the frame 356, in acounter-clockwise direction. Furthermore, as shown for example in FIGS.35 and 37, indicia may be provided on the housing 302 to aid the user inthe setting of the appropriate configuration of the OPEP device 300.

The variable nozzle 336 is shown in further detail in the front and rearperspective views of FIGS. 50 and 51. The variable nozzle 336 in theOPEP device 300 is similar to the variable nozzle 236 described abovewith regards to the OPEP device 200, except that the variable nozzle 336also includes a base plate 387 configured to fit within one end 385 (seeFIGS. 41-42) of the inner casing 303 and maintain the variable nozzle336 between the rear section 305 and the inner casing 303. Like thevariable nozzle 236, the variable nozzle 336 and base plate 387 may bemade of silicone.

The one-way valve 384 is shown in further detail in the frontperspective view of FIG. 52. In general, the one-way valve 384 comprisesa post 388 adapted for mounting in the front section 301 of the housing302, and a flap 389 adapted to bend or pivot relative to the post 388 inresponse to a force or a pressure on the flap 389. Those skilled in theart will appreciate that other one-way valves may be used in this andother embodiments described herein without departing from the teachingsof the present disclosure. As seen in FIGS. 39-40, the one-way valve 384may be positioned in the housing 302 between the mouthpiece 309 and theinhalation port 311.

As discussed above in relation to the OPEP device 100, the OPEP device300 may be adapted for use with other or additional interfaces, such asan aerosol delivery device. In this regard, the OPEP device 300 isequipped with an inhalation port 311 (best seen in FIGS. 35-36 and38-40) in fluid communication with the mouthpiece 309. As noted above,the inhalation port may include a separate one-way valve 384 (best seenin FIGS. 39-40 and 52) configured to permit a user of the OPEP device300 both to inhale the surrounding air through the one-way valve 384 andto exhale through the chamber inlet 304, without withdrawing themouthpiece 309 of the OPEP device 300 between periods of inhalation andexhalation. In addition, the aforementioned commercially availableaerosol delivery devices may be connected to the inhalation port 311 forthe simultaneous administration of aerosol therapy (upon inhalation) andOPEP therapy (upon exhalation).

The OPEP device 300 and the components described above are furtherillustrated in the cross-sectional views shown in FIGS. 39-40. Forpurposes of illustration, the cross-sectional view of FIG. 39 is shownwithout all the internal components of the OPEP device 300.

The front section 301, the rear section 305, and the inner casing 303are assembled to form a first chamber 314 and a second chamber 318. Aswith the OPEP device 100, an exhalation flow path 310, identified by adashed line, is defined between the mouthpiece 309 and at least one ofthe first chamber outlet 306 (best seen in FIGS. 39-40 and 42) and thesecond chamber outlet 308 (best seen in FIG. 41), both of which areformed within the inner casing 303. As a result of the inhalation port311 and the one-way valve 348, the exhalation flow path 310 begins atthe mouthpiece 309 and is directed toward the chamber inlet 304, whichin operation may or may not be blocked by the restrictor member 330.After passing through the chamber inlet 304, the exhalation flow path310 enters the first chamber 314 and makes a 180° turn toward thevariable nozzle 336. After passing through an orifice 338 of thevariable nozzle 336, the exhalation flow path 310 enters the secondchamber 318. In the second chamber 318, the exhalation flow path 310 mayexit the second chamber 318, and ultimately the housing 302, through atleast one of the first chamber outlet 306 or the second chamber outlet308. Those skilled in the art will appreciate that the exhalation flowpath 310 identified by the dashed line is exemplary, and that airexhaled into the OPEP device 300 may flow in any number of directions orpaths as it traverses from the mouthpiece 309 or chamber inlet 304 tothe first chamber outlet 306 or the second chamber outlet 308. Aspreviously noted, the administration of OPEP therapy using the OPEPdevice 300 is otherwise the same as described above with regards to theOPEP device 100.

Solely by way of example, the follow operating conditions, orperformance characteristics, may be achieved by an OPEP device accordingto the OPEP device 300, with the adjustment dial 354 set for increasedfrequency and amplitude:

Flow Rate (lpm) 10 30 Frequency (Hz) 7 20 Upper Pressure (cm H2O) 13 30Lower Pressure (cm H2O) 1.5 9 Amplitude (cm H2O) 11.5 21The frequency and amplitude may decrease, for example, by approximately20% with the adjustment dial 354 set for decreased frequency andamplitude. Other frequency and amplitude targets may be achieved byvarying the particular configuration or sizing of elements, for example,increasing the length of the vane 332 results in a slower frequency,whereas, decreasing the size of the orifice 338 results in a higherfrequency. The above example is merely one possible set of operatingconditions for an OPEP device according to the embodiment describedabove.Pressure Indicators for OPEP Devices

The medical industry lacks inexpensive, ergonomic, compact, and portablepressure indicator solutions for OPEP devices. For example, mostcommercially available manometers are large stationary deviceconnectable through tubing, which makes them cumbersome andunattractive. Also, most commercially available manometers are intendedto be reusable, which leads to risks of transmitting infectiousdiseases. Furthermore, existing manometers are not designed or intendedto read and provide visual feedback of oscillating pressures, such asthose generated in an OPEP device during administration of OPEP therapy.Use of such manometers with OPEP devices leads to excessive fluctuationin the pressure reading output, making it hard for a user of the device,or his or her clinician, to get accurate feedback.

The embodiments described herein provide an ergonomic pressure indicatorthat is easily integrated with existing OPEP devices, and is suitablefor repeated use by a single patient. Furthermore, these embodiments areconfigured to minimize oscillations in the visual feedback provided tothe user, therefore allowing the pressure indicator to display areadable pressure level, and at the same time, provide dynamic visualfeedback to the let user know that the OPEP device is working by sensingits oscillating pressures.

While the pressure indicator embodiments described herein are shown anddescribed for use with the OPEP device 300 of FIG. 35, it should beappreciated that the pressure indicators are also suitable for use withother OPEP devices, including for example: other OPEP embodimentsdescribed herein; those shown and described in U.S. Pat. Nos. 5,018,517;6,581,598; 6,776,159; 7,059,324; 8,327,849; 8,539,951; and 8,485,179,the entireties of which are herein incorporated by reference; thoseshown and described in U.S. patent application Ser. Nos. 13/489,894 and14/092,091, the entireties of which are herein incorporated byreference; and, any number of commercially available OPEP devices, suchas AEROBIKA® from Trudell Medical International of London, Canada,ACAPELLA® from Smiths Medical of St. Paul, Minn., FLUTTER® from AxcanScandipharm Inc. of Birmingham, Ala., and RC-CORONET® from Curaplex ofDublin, Ohio.

First Embodiment of a Pressure Indicator

Turning to FIGS. 53-56, a first embodiment of a pressure indicator 400is shown. In general, the pressure indicator 400 includes a body 402, aconduit 404 extending from the body 402, a plug 406 positioned along andinserted into the conduit 404, and an instrument for measuring pressurein the form of a manometer 408 positioned at an outlet of the conduit404.

The body 402 may be sized and shaped for integration with existing OPEPdevices, for example, as shown in FIG. 54, with the mouthpiece 309 ofthe OPEP device 300. In this example, the body 402 is comprised of 22 mmISO male/female conical connectors shaped and sized to connect to themouthpiece 309 of the OPEP device 300.

Extending from the body 402 is a conduit 404 configured to transmit apressure from within the OPEP device 300 to the manometer 408. An inlet405 permits a pressure within the body 402 to pass into the conduit 404.As shown, the conduit 404 extends away from the body 402, then anglesalongside the OPEP device 300, thereby maintaining the portability andergonomics of the OPEP device 300, and avoiding the need for lengthytubing or additional attachments.

The manometer 408 is positioned at an outlet 403 of the conduit 404. Itshould be appreciated, however, that a portion of the conduit 404 couldextend into a passageway in the manometer 408, or other instrument formeasuring pressure. The manometer 408 may be a piston-type gauge suchas, for example, an AMBU® Disposable Pressure Manometer from Ambu A/S ofCopenhagen, Denmark. Other instruments for measuring pressure may alsobe used in place of the manometer 408. In general, the manometer 408includes a spring-loaded piston that moves an indicator within thepiston in response to a change in pressure. Preferably, the instrumentfor measuring pressure may comprise one or more of a numerical, color,shape, or other visual indicia, or one or more of a sound or otherauditory indicia, or a combination of one or more of each of a visualindicia and an auditory indicia. In one of the exemplary embodimentsshown in FIG. 53, the manometer 408 includes a numerical indicia 409 ofpressures measured by the manometer 408. Preferably, the instrument formeasuring pressure is positioned relative to the respiratory treatmentdevice such that the indicator and indicia are visible to the userduring treatment. As shown in the exemplary embodiment in FIG. 54, themanometer 408 is positioned relative to the respiratory treatment devicein the form of an OPEP device 300 such that the indicator and indicia409 are viewable to a user of the OPEP device 300 during treatment.

The plug 406 is insertable by press-fitting along the conduit 404 at apoint where the conduit 404 angles alongside the OPEP device 300. In oneembodiment, the plug may not be removed, but may be made of aself-sealing material, such as a silicone material, allowing a needle orother similar instrument to be inserted and removed for cleaningpurposes while maintaining a seal. In another embodiment, the plug maybe periodically removed for cleaning of the pressure indicator 400. Asbest seen in FIGS. 56C-E, the plug 406 includes a cutout 409 that may bealigned with a passage 410 in the conduit 404. When the plug 406 isinserted into the conduit 404 such that the cutout 409 is partially orcompletely aligned with the passage 410, a pressure stabilizing orifice407 is formed in the conduit 404. As explained below, the pressurestabilizing orifice 407 is configured to dampen oscillations in thepressures transmitted from the OPEP device 300 to the manometer 408.

As shown in FIGS. 56C-E, the size and shape of the pressure stabilizingorifice 407 may be selectively adjustable by rotating the plug 406relative to the passage 410, thereby increasing or decrease the amountof dampening. While the pressure stabilizing orifice 407 is shown asbeing adjustable, it should be appreciated that the size and shape ofthe pressure stabilizing orifice 407 may be fixed. Furthermore, itshould be appreciated that the pressure stabilizing orifice 407 may bepositioned anywhere along the conduit 404 between the body 402 and themanometer 408, for example, as seen in FIG. 56F, or in a portion of theconduit 404 extending into the manometer 408, or in a passageway formingpart of the instrument for measuring pressure, for example, as seen inFIG. 56G. However, in order for the pressure stabilizing orifice 407 toeffectively dampen oscillations in the pressures transmitted from theOPEP device 300 to the manometer 408, the cross-sectional area of thepressure stabilizer orifice 407 should be less than a cross-sectionalarea of the conduit 404 along the entire length of the conduit 404. Inthis embodiment, the pressure stabilizer orifice 407 has a diameter of0.5 mm to 1.5 mm, or a cross-sectional area between 0.196 mm² and 1.767mm². Preferably, the pressure stabilizer orifice 507 has a diameter of0.6 mm to 0.9 mm, or a cross-sectional area between 0.283 mm² and 0.636mm².

As explained in greater detail above with reference to the various OPEPembodiments, during administration of OPEP therapy, an oscillating backpressure is transmitted to the user of the OPEP device, which isreceived by the user at the mouthpiece. When the pressure indicator 400is connected to such an OPEP device, for example the OPEP device 300,the oscillating pressure is transmitted from within the body 402 to themanometer 408 through the conduit 404. The oscillations in the pressureare dampened, however, by the pressure stabilizing orifice 407, as theflow of air along the conduit 404 through the pressure stabilizingorifice 407 is restricted. After the pressure has been dampened by thepressure stabilizing orifice 407, it is received and measured by themanometer 408, which in turn provides the user with a visual indicationof the pressure achieved during administration of OPEP therapy. Thisallows the user or caregiver to monitor the treatment regimen or therapyto ensure that the appropriate pressures are achieved for the prescribedperiod of time. In some instances, a treatment regimen or therapyalternating between exhalation at a high pressure for a predeterminedperiod of time and exhalation at a low pressure for a predeterminedperiod of time may be desirable. A visual or auditory indication of thepressure achieved during treatment will allow the user or caregiver todetermine the level of compliance with the prescribed treatment regimenor therapy.

Turning to FIGS. 56H-56I, an illustration is provided comparing theoscillations in pressures observed using a pressure indicator accordingto the present embodiment without a pressure stabilizing orifice (FIG.56H) to a pressure indicator according to the present embodiment with apressure stabilizing orifice (FIG. 56I) when used in conjunction with anAEROBIKA® OPEP device from Trudell Medical International of London,Canada. The observed pressures are also set forth in the followingtable:

OPEP Device Pressure Oscillations Pressure Oscillations Pressure WithoutStabilizing Orifice With Stabilizing Orifice (cm-H₂O) (cm-H₂O) (cm-H₂O)30 7 1 20 5 0.7 10 4 0.5 5 3 0.4It is further observed that use of the pressure indicator 400 does notadversely affect the performance of the OPEP device to which it isattached, or to the delivery of aerosolized medication from a nebulizerattached to such an OPEP device.

Second Embodiment of a Pressure Indicator

Turning to FIGS. 57-59, a second embodiment of a pressure indicator 500is shown. In general, the pressure indicator 500 includes a body 502, aconduit 504 extending from the body 502, a cap 506 positioned along theconduit 504, and an instrument for measuring pressure in the form of amanometer 508 positioned at an outlet of the conduit 504.

The body 502 may be sized and shaped for integration with existing OPEPdevices, for example, as shown in FIG. 58, with the mouthpiece 309 ofthe OPEP device 300. In this example, the body 502 is again comprised of22 mm ISO male/female conical connectors shaped and sized to connect tothe mouthpiece 309 of the OPEP device 300.

Extending from the body 502 is a conduit 504 configured to transmit apressure from within the OPEP device 300 to the manometer 508. An inlet505 permits a pressure within the body 502 to pass into the conduit 504.As shown, the conduit 504 extends away from the body 502 only a shortdistance to allow for connection to the manometer 508, therebymaintaining the portability and ergonomics of the OPEP device 300, andavoiding the need for lengthy tubing or additional attachments.

The manometer 508 is positioned at an outlet 503 of the conduit 504. Itshould be appreciated, however, that a portion of the conduit 504 couldextend into the instrument for measuring pressure, such as the manometer508. The manometer 508 may be a dial-type gauge such as, for example, aMERCURY MEDICAL® Disposable Pressure Manometer from Mercury Medical ofClearwater, Fla. Other instruments suitable for measuring pressure froma respiratory treatment device, such as an OPEP device, may also be usedin place of the manometer 508. In general, the manometer 508 includes anindicator that in one embodiment is rotated in response to a change inpressure. Preferably, the manometer 408 includes an indicia 409 ofpressures measured by the manometer, e.g., numbers, color coding, etc.As shown, the manometer 508 is positioned relative to the OPEP device300 such that the indicator and indicia 509 are viewable to a user ofthe OPEP device 300 during treatment.

A pressure stabilizing orifice 507 is positioned along the conduit 504.However, the pressure stabilizing orifice 507 could also be positionedin a portion of the conduit 504 extending into the manometer 508, or theconduit or other passageway forming part of the instrument for measuringpressure. In this embodiment, the pressure stabilizer orifice 507 has afixed shape and size, and a diameter of 0.5 mm to 1.5 mm, or across-sectional area between 0.196 mm² and 1.767 mm². Preferably, thepressure stabilizer orifice 507 has a diameter of 0.6 mm to 0.9 mm, or across-sectional area between 0.283 mm² and 0.636 mm².

The cap 506 is insertable into the conduit 504 by press-fitting. The cap506 may be periodically removed for cleaning of the pressure indicator500. Unlike the plug 406 in the pressure indicator 400, the cap 506 doesnot align with a passage, and does not form part of the pressurestabilizing orifice 507.

The pressure indicator 500 otherwise operates in the same manner as thepressure indicator 400 described above.

Turning to FIGS. 59D-59E, an illustration is provided comparing theoscillations in pressures observed using a pressure indicator accordingto the present embodiment without a pressure stabilizing orifice (FIG.59D) to a pressure indicator according to the present embodiment with apressure stabilizing orifice (FIG. 59E) when used in conjunction with anAEROBIKA® OPEP device from Trudell Medical International of London,Canada. The observed pressures are also set forth in the followingtable:

OPEP Device Pressure Oscillations Pressure Oscillations Pressure WithoutStabilizing Orifice With Stabilizing Orifice (cm-H₂O) (cm-H₂O) (cm-H₂O)30 12 1 20 9 0.9 15 7 0.7 10 5 0.5 5 3 0.4It is further observed that use of the pressure indicator 500 does notadversely affect the performance of the OPEP device to which it isattached, or to the delivery of aerosolized medication from a nebulizerattached to such an OPEP device.

Third Embodiment of a Pressure Indicator

Turning to FIGS. 60-61, a third embodiment of a pressure indicator 600is shown connected to the OPEP device 300. The pressure indicator 600differs from the pressure indicator 500 in that the pressure indicator600 is sized and shaped for integration with existing OPEP devices, forexample, as shown in FIG. 60, with the inhalation port 311 of the OPEPdevice 300 (see also, FIGS. 35-35 and 40).

As with the pressure indicator 500, the pressure indicator 600 includesa body 602, a conduit 604 extending from the body 602, an inlet 605 andan outlet 603 to the conduit 604, a cap 606 positioned along the conduit604, a dial-type manometer 608 positioned at an end of the conduit 604,and a pressure stabilizer orifice 607. As shown, the manometer 608 ispositioned relative to the OPEP device 300 such that the indicator andindicia are viewable to a caregiver and/or a user of the OPEP device 300during treatment.

The pressure indicator 600 further includes a one-way valve 684positioned within the body 602, and a prong 612 that extends from withinthe body 602 into the inhalation port 311 of the OPEP device 300. Theone-way valve 684 is configured to open upon inhalation at themouthpiece 309 of the OPEP device 300, and close upon exhalation. Theprong 612 is configured to hold the one-way valve 384 in an openpositioned, thereby placing the body 602 in fluid communication with themouthpiece 309.

In operation, the pressure indicator 600 is configured to operate in thesame manner as the pressure indicator 500 described above, and providethe same visual feedback as the pressure indicator 500 connected to themouthpiece 309 of the OPEP device 300.

Fourth Embodiment of a Pressure Indicator

Turning to FIGS. 62-63, a fourth embodiment of a pressure indicator 700is shown connected to the OPEP device 300. The pressure indicator 700differs from the pressure indicator 400 in that the pressure indicator700 is sized and shaped for integration with existing OPEP devices, forexample, as shown in FIG. 62, with the inhalation port 311 of the OPEPdevice 300 (see also, FIGS. 35-35 and 40).

As with the pressure indicator 400, the pressure indicator 700 includesa body 702, a conduit 704 extending from the body 702, an inlet 705 andan outlet 703 to the conduit 704, a plug 706 positioned along theconduit 704, a piston-type manometer 708 positioned at an end of theconduit 704, and a pressure stabilizer orifice 707. As shown, themanometer 708 is positioned relative to the OPEP device 300 such thatthe indicator and indicia are viewable to a user of the OPEP device 300during treatment.

Like the pressure indicator 600, the pressure indicator 700 furtherincludes a one-way valve 784 positioned within the body 702, and a prong712 that extends from within the body 702 into the inhalation port 711of the OPEP device 300. The one-way valve 784 is configured to open uponinhalation at the mouthpiece 309 of the OPEP device 300, and close uponexhalation. The prong 712 is configured to hold the one-way valve 384 inan open positioned, thereby placing the body 702 in fluid communicationwith the mouthpiece 709.

In operation, the pressure indicator 700 is configured to operate in thesame manner as the pressure indicator 400 described above, and providethe same visual feedback as the pressure indicator 400 connected to themouthpiece 309 of the OPEP device 300.

Fifth Embodiment

As noted above with respect to pressure indicator 400, the pressurestabilizing orifice may be positioned anywhere along the conduit betweenthe body and the manometer, for example, as seen in FIG. 56F, or in aportion of the conduit extending into the manometer, or in a passagewayforming part of the instrument for measuring pressure, for example, asseen in FIG. 56G. It should further be appreciated that one or morepressure stabilizing orifices may be positioned within the manometer,for example, at an inlet to the manometer, at a vent for the manometer,or at both the inlet and the vent, to dampen the oscillations in thepressure measured by the manometer.

Turning to FIG. 64A, an illustration is provided showing a manometer408′, for example an AMBU® Disposable Pressure Manometer from Ambu A/Sof Copenhagen, Denmark. In general, the manometer 408′ includes achamber 490, an air inlet 491, one or more openings forming a vent 492,and a membrane 493 disposed therebetween. The membrane 493 divides thechamber 490 in two, creating a side exposed to the pressures obtained inthe OPEP device, and a side exposed to atmospheric pressure. As airflows from the OPEP device into the chamber through the inlet 491, thepressure increases in the chamber 490 on the OPEP side, causing themembrane 493 to expand and expel the air on the side of the chamber 490exposed to atmospheric pressure through the vent 492. As shown in FIG.64A, the inlet 491 has a diameter of 3 mm and a cross-sectional area of7.1 mm², while the vent 492 is comprised of four rectangular openings(4.6 mm by 1.8 mm) having a combined cross-sectional area of 33 mm².

As shown in FIG. 64B, one or more pressure stabilizing orifices may bepositioned within the manometer 408′, at the inlet 491 to the manometer408′, at the vent 492 for the manometer 408′, or at both the inlet 491and the vent 492. For example, a pressure stabilizing orifice 494positioned at the inlet 491 may have a diameter of 0.6 mm to 0.9 mm, ora cross-sectional area of 0.283 mm² to 0.636 mm². A pressure stabilizingorifice 495 may also be positioned at the vent 492, which as shown inFIG. 64B includes four rectangular openings. Like the cross-sectionalarea of the pressure stabilizing orifice 494 positioned at the inlet491, the combined cross-sectional area of the openings forming thepressure stabilizing orifice 495 positioned at the vent 492 ranges from0.283 mm² to 0.636 mm². As noted above, a pressure stabilizing orificecould be positioned at the inlet 491, at the vent 492, or at both theinlet 491 and the vent 492. By restricting the flow of air into themanometer 408′ through the inlet, or out of the manometer 408′ throughthe vent 492, the pressure stabilizing orifice dampens oscillations inthe pressures measured by the manometer 408′, thereby allowing thepressure indicator to display a readable pressure level, and at the sametime, provide dynamic visual feedback to let the user know that the OPEPdevice is working.

Similarly, turning to FIG. 65A, an illustration is provided showing amanometer 508′, for example a MERCURY MEDICAL® Disposable PressureManometer from Mercury Medical of Clearwater, Fla. In general, themanometer 508′ includes a chamber 590, an air inlet 591, one or moreopenings forming a vent 592, and a membrane 593 disposed therebetween.The membrane 593 divides the chamber 590 in two, creating a side exposedto the pressures obtained in the OPEP device, and a side exposed toatmospheric pressure. As air flows from the OPEP device into the chamberthrough the inlet 591, the pressure increases in the chamber 590 on theOPEP side, causing the membrane 593 to expand and expel the air on theside of the chamber 590 exposed to atmospheric pressure through the vent592. As shown in FIG. 65A, the inlet 591 has a diameter of 2.45 mm,while the vent 492 is comprised of two openings each having a diameterof 2 mm.

As shown in FIG. 65B, one or more pressure stabilizing orifices may bepositioned within the manometer 508′, at the inlet 591 to the manometer508′, at the vent 592 for the manometer 508′, or at both the inlet 591and the vent 592. For example, a pressure stabilizing orifice 594positioned at the inlet 591 may have a diameter of 0.6 mm to 0.9 mm, ora cross-sectional area of 0.283 mm² to 0.636 mm². A pressure stabilizingorifice 595 may also be positioned at the vent 592, which as shown inFIG. 65B includes two openings. Like the cross-sectional area of thepressure stabilizing orifice 594 positioned at the inlet 591, thecombined cross-sectional area of the openings forming the pressurestabilizing orifice 595 positioned at the vent 592 ranges from 0.283 mm²to 0.636 mm². As noted above, a pressure stabilizing orifice could bepositioned at the inlet 591, at the vent 592, or at both the inlet 591and the vent 592. By restricting the flow of air into the manometer 508′through the inlet, or out of the manometer 58′ through the vent 4592,the pressure stabilizing orifice dampens oscillations in the pressuresmeasured by the manometer 508′, thereby allowing the pressure indicatorto display a readable pressure level, and at the same time, providedynamic visual feedback to the let user know that the OPEP device isworking.

Additional Implementations

As previously noted, the pressure indicator embodiments described hereinmay be used with other OPEP devices, including for example: an ACAPELLA®OPEP device 810 from Smiths Medical of St. Paul, Minn., as shown inFIGS. 66-67; a FLUTTER® OPEP device 820 from Axcan Scandipharm Inc. ofBirmingham, Ala., as shown in FIGS. 68-69; and, an RC-CORONET® OPEPdevice 830 from Curaplex of Dublin, Ohio, as shown in FIG. 70-71.

Installation and Use Restriction Features

Turning to FIGS. 72-74, another embodiment of a pressure indicator 400′is shown. Except as noted below, the pressure indicator 400′ isotherwise the same as the pressure indicator 400 described above, and isconfigured to operate in the same manner as the pressure indicator 400,and provide the same visual feedback as the pressure indicator 400.

FIG. 72 is a perspective view of the alternative embodiment of apressure indicator 400′, shown without a manometer, which includesfeatures that prevent unintended installations and restrict use to anapproved respiratory treatment device. FIG. 73 is a differentperspective view of the pressure indicator 400′, shown with a manometer408′, during an unintended installation on the OPEP device 300 of FIG.35. FIG. 74 is a side-view of the pressure indicator 400′, afterinstallation on an approved respiratory treatment device, such as theOPEP device 300.

In general, as with the pressure indicator 400, and as seen in FIG. 72,the pressure indicator 400′ includes a body 402′, a conduit 404′extending from the body 402′, and a plug 406′ positioned along andinserted into the conduit 404′. Although not shown in FIG. 72, thepressure indicator 400′ also includes an instrument for measuringpressure in the form of a manometer 408′ positioned at an outlet 403′ ofthe conduit 404′, as seen in FIGS. 73-74. The body 402′ may be sized andshaped for integration with existing OPEP devices, for example, as shownin FIG. 74, with the mouthpiece 309 of the OPEP device 300. In thisembodiment, the body 402′ is comprised of 22 mm ISO male/female conicalconnectors shaped and sized to connect to the mouthpiece 309 of the OPEPdevice 300, and the OPEP device 300 itself.

As shown in FIGS. 72-73, the pressure indicator 400′ includes an annualring or flange 412′ disposed at one end of the housing 402′ thatprevents unintended installations, such as seen in FIG. 73.Specifically, when a user attempts to install the pressure indicator400′ on an OPEP device 300 in a backwards or reversed orientation, theflange 412′ contacts an extension 350 extending from the housing 302 ofthe OPEP device 300, such that the corresponding 22 mm ISO male/femaleconical connectors on the pressure indicator 400′ and the OPEP device300 are prevented from connecting. As seen in FIG. 74, the flange 402′does not prevent the 22 mm ISO male/female conical connectors on thepressure indicator 400′ and the mouthpiece 309 of the OPEP device 300from connecting. In this way, a user is prevented from installing thepressure indicator 400′ on an OPEP device 300 in a backwards or reversedorientation.

As shown in FIGS. 72 and 74, the pressure indicator 400′ also includes acollar 414′ disposed at an end of the housing 402′ opposite the flange412′ that restricts use of the pressure indicator 400′ to an approvedrespiratory treatment device. As shown in FIG. 74, the approvedrespiratory treatment device may be the OPEP device 300. Specifically,when a user attempts to install the pressure indicator 400′ on the OPEPdevice 300 in the intended orientation, a specific contour 415′ of thecollar 414′ on the pressure indicator 400′ aligns with a correspondingspecific contour 352 of a collar 354 on the OPEP device 300, such thatthe 22 mm ISO male/female conical connectors on the pressure indicator400′ and the OPEP device 300 may fully engage and complete a connection.However, if a user attempts to install the pressure indicator 400′ on arespiratory treatment device that does not have a specific contourintended to correspond to and receive the specific contour 415′ of thecollar 414′ on the pressure indicator 400′, the collar 414 will likelycontact with the respiratory treatment device in a manner that preventsconnection of the 22 mm ISO/male/female connector on the pressureindicator 400′ with the respiratory treatment device. If should beappreciated that the specific contour 415′ of the collar 414′ and thecorresponding specific contour 352 of the collar 354 on the OPEP deviceare merely exemplary, and that any number of other contours or keyedpatterns may be used. In this way, use of the pressure indicator 400′may be restricted to an approved respiratory treatment device like theOPEP device 300.

Although the foregoing description is provided in the context of OPEPdevices, it will also be apparent to those skilled in the art that otherrespiratory treatment devices may benefit from various teachingscontained herein. The foregoing description has been presented forpurposes of illustration and description, and is not intended to beexhaustive or to limit the inventions to the precise forms disclosed. Itwill be apparent to those skilled in the art that the present inventionsare susceptible of many variations and modifications coming within thescope of the following claims.

What is claimed is:
 1. A portable pressure indicator for an oscillatingpositive expiratory pressure (“OPEP”) device, the portable pressureindicator comprising: a first conduit having a first opening configuredto transmit a flow of air and a second opening configured to fluidlycommunicate with the OPEP device; a second conduit extending laterallyfrom the first conduit; a manometer supported by and connected to thesecond conduit, the manometer being configured to measure and indicateoscillating positive expiratory pressures generated by the OPEP device;and, a pressure stabilizing orifice positioned within the secondconduit, the pressure stabilizing orifice being configured to dampen theoscillating positive expiratory pressures generated by the OPEP device;wherein the pressure stabilizing orifice has a cross-sectional areabetween 0.196 mm² and 1.767 mm².
 2. The pressure indicator of claim 1,wherein the second conduit comprises a first portion angled outward fromthe first conduit and a second portion extending parallel to the secondconduit.
 3. The pressure indicator of claim 2, wherein the secondportion of the second conduit is spaced from the first conduit by adistance less than a length of the first portion of the second conduit.4. The pressure indicator of claim 1, wherein the first conduit is open,such that the flow of air between the first opening and the secondopening is unobstructed.
 5. The pressure indicator of claim 1, furthercomprising a one-way valve positioned between the first opening and thesecond opening, the one-way valve configured to remain closed inresponse to oscillating positive expiratory pressures generated by theOPEP device.
 6. The pressure indicator of claim 1, further comprising aprojection extending from the first conduit through the second opening.7. The pressure indicator of claim 1, wherein the manometer isconfigured to measure pressure exceeding 5 cm H₂O.
 8. The pressureindicator of claim 1, wherein a cross-sectional area of the pressurestabilizing orifice is less than a cross-sectional area of the secondconduit along an entire length of the second conduit.
 9. The pressureindicator of claim 1, wherein the manometer comprises a membraneconfigured to block the flow of air through the manometer to asurrounding atmosphere.
 10. The pressure indicator of claim 1, wherein across-sectional area of the pressure stabilizing orifice is selectivelyadjustable to increase or decrease an amount of dampening.
 11. Thepressure indicator of claim 1, wherein a cross-sectional area of thesecond conduit is smaller than a cross-sectional area of the firstconduit.
 12. A portable pressure indicator for an oscillating positiveexpiratory pressure (“OPEP”) device, the portable pressure indicatorcomprising: a first conduit having a first opening configured totransmit a flow of air and a second opening configured to fluidlycommunicate with the OPEP device; a second conduit comprising a firstportion extending laterally from the first conduit and a second portionangled relative to the first portion, wherein the second portion of thesecond conduit is spaced from the first conduit by a distance less thana length of the first portion of the second conduit, wherein a positionof the second conduit is fixed relative to a position of the firstconduit; a manometer supported by and connected to the second portion ofthe second conduit, the manometer being configured to measure andindicate oscillating positive expiratory pressures generated by the OPEPdevice.
 13. The pressure indicator of claim 12, further comprising aone-way valve positioned between the first opening and the secondopening, the one-way valve configured to remain closed in response tooscillating positive expiratory pressures generated by the OPEP device.14. The pressure indicator of claim 12, further comprising a projectionextending from the first conduit through the second opening.
 15. Thepressure indicator of claim 12, further comprising a pressurestabilizing orifice positioned within the second conduit, the pressurestabilizing orifice being configured to dampen the oscillating positiveexpiratory pressures generated by the OPEP device.
 16. The pressureindicator of claim 15, wherein a cross-sectional area of the pressurestabilizing orifice is selectively adjustable to increase or decrease anamount of dampening.
 17. The pressure indicator of claim 12, wherein across-sectional area of the second conduit is smaller than across-sectional area of the first conduit.
 18. A portable pressureindicator for an oscillating positive expiratory pressure (“OPEP”)device, the portable pressure indicator comprising: a first conduithaving a first opening configured to transmit a flow of air and a secondopening configured to fluidly communicate with the OPEP device; a secondconduit comprising a first portion extending laterally from the firstconduit and a second portion angled relative to the first portion,wherein the second portion of the conduit is spaced from the firstconduit by a distance less than a length of the first portion of thesecond conduit; a manometer supported by and connected to the secondconduit, the manometer being configured to measure and indicateoscillating positive expiratory pressures generated by the OPEP device,and comprising a membrane configured to block the flow of air throughthe manometer to a surrounding atmosphere; and, a pressure stabilizingorifice positioned within the second conduit, the pressure stabilizingorifice being configured to dampen the oscillating positive expiratorypressures generated by the OPEP device; wherein the pressure stabilizingorifice has a cross-sectional area between 0.196 mm² and 1.767 mm². 19.The pressure indicator of claim 18, wherein a cross-sectional area ofthe second conduit is smaller than a cross-sectional area of the firstconduit.